The FDA seem to be keen to get some drugs out into the market before the jury has reached a conclusion.
Aducanumab has just been approved for alzheimers as an example.
https://www.statnews.com/2021/06/07/fda-aducanumab-approval-paves-way-momentous-alzheimers-breakthroughs/
https://www.fiercepharma.com/pharma/biogen-fda-aducanumab-decision
Good data for Paxalisib will likely have a very receptive audience at the FDA.